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Chelation Therapy Jodie Baunsgard FSCN 547 Summer 2006 Learning Objectives • What claims are being made about chelation therapy? • What is chelation therapy commonly used for? • How can chelation therapy be toxic? • Why is chelation therapy being used to treat Coronary Artery Disease (CAD)? • What conclusions were made by the 2000 study made by University of Calgary? • What is the current TACT study hoping to achieve in their 5-year study on chelation therapy? What is Chelation Therapy? • Chelation (KEE-LAY-SHUN) comes from the Greek word – “chele”which means claw. • “the use of a chelating agent to bind with a metal in the body to form a chelate so that the metal loses its toxic effect or physiological activity” ~Merriam-Webster's Medical Dictionary What is Chelation Therapy? • Chelation therapy is an investigational form of complementary or alternative therapy that uses the man-made amino acid, called EDTA (ethylene diamine tetra acetic acid). • EDTA is administered via an IV. www.fitchicago.com Chelation- claw-like formation www.mcdonaghmed.com/images/Chelation5.jp g Common Uses of Chelation Therapy • Chelation therapy has primarily been used as agent to detoxify heavy metals such as calcium, iron, magnesium, lead and zinc. • EDTA binds to these metal ions because of its strong affinity for cations. • The bound metal ions are then excreted in the urine. Toxicities Related to Chelation Therapy • chelation therapy must be used with supplementation of calcium • There have been a few deaths recorded related to hypocalcemia as a result of chelation therapy -stroke- calcium facilitates the conversion of prothrombin - > thrombin -heart attacks – calcium helps to regulate heartbeats History of Chelation Therapy • EDTA the chelation agent developed in Germany during WWII as a substitute for citric acid, because supplies were scarce. • Brought to the US in 1947. • 1950s-Determined effective especially with lead detoxification • 1960- current- toxicologists begin testing chelation therapy with CAD patients Claims of Chelation Therapy Many claims…very little proof… • CAD • Alzheimer’s Disease • Neurodevelopment diseases related to toxic metals • Autism Spectrum Disorder Chelation Therapy and CAD • Chelation Therapy and Coronary Artery Disease is a contemporary hot topic of much controversy in the medical realm. • It is an investigational theory that is currently being tested to determine if chelation therapy can be used to remove plaque from coronary arteries. How it possibly works to decrease CAD • Atheromatous plaque is one of the leading causes of CAD. • A major component of plaque is calcium. • 3-Theories of plaque removal: – EDTA might break up atheromatous plaque. – EDTA may activate a hormone that sets calcium free. – Chelation therapy may reduce oxidative stress on walls of blood vessels. Atherosclerotic Artery www.mcdonaghmed.com Criteria for Usage of Chelation Therapy with CAD Patients using Chelation therapy must follow strict criteria: • CAD must be in a stable state • Prior to treatment patient must have cardiac function measured using a electrocardiogram ECG • functioning kidney and liver • Normal blood count • No cancerous growth and no other infectious immune compromising diseases • Need to have a nutrition screen done • Must continue regular CAD treatment with physician The Scientific Evidence (3 Studies: 1 Meta-analysis 2 studies) Shrihari, JS, et al., Role of EDTA chelation therapy in cardiovascular diseases. The National Medical Journal of India, (2006)19. • Objective: To analyze data retrieved from various studies to determine the efficacy of chelation therapy on cardiovascular diseases. • Study Design: This was a meta-analysis study of 7 other studies with usage of chelation therapy • Subjects: Between 10 and 153 participants depending on study. Shrihari, JS, et al., Role of EDTA chelation therapy in cardiovascular diseases. The National Medical Journal of India, (2006)19. Authors (Year) Patient profile Kitchell et al. 196314 CAD Knudtson et al. 200215 Sample size Randomization Blinding Results 28 Not described Double No benefits CAD 84 Described Double No benefits Anderson et al. 2003 CAD 53 Described Double No benefits Olszewer et al. 1990 Peripheral AD 10 Not described Double* Improvement in walking Sloth-Nielsen et al.1991 Peripheral VD 153 Described Double No benefits Guldager et al.1992 Peripheral AD 153 Described Double No benefits van Rij et al. 1994 IHD, PV 32 Described Double No benefits Shrihari, JS, et al., Role of EDTA chelation therapy in cardiovascular diseases. The National Medical Journal of India, (2006)19. • Meta-analysis conclusion: -EDTA all with vitamins and minerals does not provide additional benefits in CAD. -Further research needs to be done in order to use chelation therapy as a definitive therapeutic modality for CAD. Chelation Therapy for the ischemic Heart Disease: A randomized controlled Trial Division of Cardiology, University of Calgary and Calgary Regional Health Authority, Calgary, Alberta, Canada. (2000) 287:4 • Objective: was to discern whether or not EDTA chelation therapy had a positive impact on an individual’s ability to exercise due to their ischemic heart, as well as measure their quality of life. • Study Design: Double-blind, placebo controlled • Subjects: 84 people, M/F, 21+, stable CAD and ability to walk on treadmill Chelation Therapy for the ischemic Heart Disease: A randomized controlled Trial Division of Cardiology, University of Calgary and Calgary Regional Health Authority, Calgary, Alberta, Canada. (2000) 287:4 Treatment Types: • EDTA Chelation Therapy • Placebo 9% solution of NaCl Outcome measures: • Exercise capacity on treadmill • Exercise time to ischemia • Quality of life measures Chelation Therapy for the ischemic Heart Disease: A randomized controlled Trial Division of Cardiology, University of Calgary and Calgary Regional Health Authority, Calgary, Alberta, Canada. (2000) 287:4 Results of study: • Similar results with both sets of participants • No evidence to support the usage of chelation therapy on patients with CAD Trial to Assess Chelation Therapy (TACT) National Center for Complementary and Alternative Medicine, National Institute of Health Bethesda, Maryland, United States of America (2002-2007) Objective: To test the efficacy of Chelation Therapy on CAD patients Study Design: Double-blind, Placebo controlled, multi-centered Subjects: TACT is the largest trial to test the efficacy of Chelation Therapy - 2372 participants - Must be receiving traditional treatment for CAD Trial to Assess Chelation Therapy (TACT) National Center for Complementary and Alternative Medicine, National Institute of Health Bethesda, Maryland, United States of America (2002-2007) • Treatment: -EDTA Chelation therapy or -Placebo solution - All patients will receive a vitamin supplement • Treatment regimen: -one a week for 30 weeks -after initial 30 treatments patients will have 10 more treatments, 2 weeks to 10 weeks apart -treatments last for 3 hours -Patients must continue standard heart treatments provided by individual physician Trial to Assess Chelation Therapy (TACT) National Center for Complementary and Alternative Medicine, National Institute of Health Bethesda, Maryland, United States of America (2002-2007) • Result of study: This study is currently be done! There aren’t any results yet! • NIH and NCCAM: Hope to provide some evidence on the efficacy of chelation therapy, because this is the largest study ever done on chelation therapy. Does it work? • What’s your opinion? Conclusion • Chelation therapy has been used as a successful treatment for toxicities with minerals lead, magnesium, zinc, calcium and iron. • Calcium is a major component of plaque that causes CAD. • At this time it is difficult to find reasonable cause to support or deny the efficacy of chelation therapy on CAD. References Knudtson, ML., et al., Chelation Therapy for Ischemic Heart Disease: A randomized Controlled Trial. JAMA, 2002; 287, 4; 481-486. http://proquest.umi.com/ Retrieved: 7/5/06 Mahan, L K., Escott-Stump, S. Krause’s Food Nutrition and Diet Therapy, 11th ed. Philidelphia: Saunders, 2004. Nash, RA., Metals in Medicine. Alternative Therapies in Health and Medicine, 2005;11, 4; 18-26. http://proquest.umi.com/ Retrieved: 6/26/06 National Center for Complementary and Alternative Medicine, National Institute of Health. Learn More About Chelation Therapy and the Study, 2006. http://nccam.nih/gov/chelation/chelationstudy.htm Retrieved: 6/23/06 Shrihari, JS, et al., Role of EDTA chelation therapy in cardiovascular diseases. The National Medical Journal of India, 2006;19. http://www.nmji/archives Retrieved: 7/5/06 Chelation Therapy The End!